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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Attest Super Rapid 5 SteamPlus Steam Challenge Pack

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  Class 2 Device Recall 3M Attest Super Rapid 5 SteamPlus Steam Challenge Pack see related information
Date Initiated by Firm August 22, 2023
Date Posted September 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-2640-2023
Recall Event ID 92915
510(K)Number K193154  
Product Classification Indicator, biological sterilization process - Product Code FRC
Product 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
Code Information UDI/DI: 50707387787283( (shipper); Lot Codes: 41482VF, exp. 33P4ND; 33P4YN, exp. 01/02/2025
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave
Bldg 275-5w-06
Saint Paul MN 55144-0001
For Additional Information Contact Jennifer Ehrlich
651-592-0132
Manufacturer Reason
for Recall		 Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.
FDA Determined
Cause 2		 Process control
Action 3M issued an Urgent product recall notice to its consignees on 08/24/2023 by email and US mail. The notice explained the problem with the product and requested the following: Discontinue distribution of the product and dispose of the product. Distributors were directed to notify their customers. The firm is offering replacement with the return of the completed response form.
Quantity in Commerce 77,280 devices
Distribution Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = 3M Company
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